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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00789464
Date of registration: 10/11/2008
Prospective Registration: No
Primary sponsor: Baylor College of Medicine
Public title: Probiotics for Girls With Recurring Urinary Tract Infections
Scientific title: H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection
Date of first enrolment: November 2008
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT00789464
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     David R. Roth, MD
Address: 
Telephone:
Email:
Affiliation:  Baylor College of Medicine
Key inclusion & exclusion criteria

Inclusion Criteria:

- Girls age 1 through age 17 years of age

- Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year
preceding study inclusion or already using any form of prophylaxis to prevent
recurrences of UTI

- Must have had at least 3 symptomatic urinary tract infections in the year before the
start of the prophylaxis.

Exclusion Criteria:

- Breastfeeding

- Pregnancy

- Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim

- Known immunosuppression i.e., transplant recipients or children with congenital
immunodeficiencies

- Poorly controlled diabetes

- Untreated HIV infection

- Use of high dose corticosteroids for autoimmune diseases or post-organ
transplantation. Inhaled corticosteroids or oral steroids for asthma are allowed.

- Malnutrition

- Patients with a history of sulfamethoxazole/trimethoprim-resistant UTI will be
excluded from the study

- Patients with renal insufficiency, liver insufficiency, or cardiopulmonary disease
requiring medication will be excluded from the study

- Patients with known anemia will be excluded from the study

- Patients taking medications that may interact with sulfamethoxazole/trimethoprim will
be excluded from the study

- Patients taking other probiotics will be excluded from the study

- Patients already taking prophylactic antibiotics will be excluded from the study



Age minimum: 3 Months
Age maximum: 17 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Recurrent Urinary Tract Infection
Intervention(s)
Drug: trimethoprim/sulfamethoxazole
Dietary Supplement: Lactobacillus reuteri DSM 17938
Primary Outcome(s)
The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. [Time Frame: 1 year]
Secondary Outcome(s)
Secondary ID(s)
H-23187
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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